Neurostimulator Titration Interface With Patient Feedback
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Solution Overview
Problem
The standard titration process for vagus nerve stimulation (VNS) therapy is time-consuming and inefficient, particularly for patients with urgent conditions like chronic heart failure, as it requires frequent physician visits and can lead to prolonged periods without receiving full therapeutic intensity, risking condition degradation.
Innovation Solution
A management device and method that allows for remote monitoring and adjustment of VNS parameters using a user interface, enabling automated titration based on real-time data and patient feedback, minimizing side effects and accelerating the titration process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional physician-controlled titration process is used, then patient safety and tolerance management are improved, but treatment time is extended and productivity deteriorates
Solution Approach 1:
The system enables automated titration where the neurostimulator automatically adjusts stimulation parameters based on pre-programmed protocols and patient feedback, eliminating the need for continuous physician intervention. The device autonomously manages the titration process while maintaining safety through programmed constraints and patient-reported side effect monitoring.
Solution Approach 2:
The system incorporates real-time feedback mechanisms where patients report side effects through the user interface, and the system automatically responds by adjusting stimulation parameters. This closed-loop feedback allows rapid adaptation to patient tolerance while maintaining safety, significantly accelerating the titration process compared to traditional periodic physician visits.
2Manufacturing precision
If frequent physician visits are scheduled for titration adjustments, then titration precision is improved, but patient convenience and ease of operation worsen
Solution Approach 1:
Patients can directly interact with the neurostimulator through a simplified user interface to report side effects and receive automatic parameter adjustments without leaving their environment. The device performs self-adjustments based on patient feedback, eliminating the need for frequent clinic visits while maintaining titration precision through automated algorithms.
Solution Approach 2:
The system introduces an automated intermediary process between patient needs and parameter adjustments. Rather than requiring direct physician-patient interaction for each adjustment, the automated system mediates the titration process by interpreting patient feedback and implementing appropriate parameter changes, thereby improving convenience while preserving precision.
3Productivity
If full therapeutic intensity is delivered immediately, then treatment effectiveness is improved, but patient discomfort and harmful factors increase
Solution Approach 1:
The system performs preliminary actions by pre-programming titration protocols that gradually increase stimulation intensity over time. Before delivering full therapeutic intensity, the system automatically progresses through intermediate intensity levels, allowing the patient's nervous system to adapt and tolerance to develop, thereby eliminating initial discomfort while ensuring eventual delivery of full therapeutic benefit.
Solution Approach 2:
The system dynamically adjusts stimulation parameters based on real-time patient feedback and pre-programmed protocols. Rather than delivering static full-intensity stimulation, the system continuously adapts the intensity level to match patient tolerance, which evolves over time. This dynamic approach ensures treatment effectiveness is maximized while discomfort is minimized at each stage of adaptation.
Data Source
AI summary
Systems and methods for a user interface for titration of an implantable neurostimulator are provided. A method of managing titration using a management device for a patient implanted with a neurostimulator includes receiving, from the neurostimulator, data for the patient relating to stimulation being provided to the patient by the neurostimulator while the neurostimulator is in communication with the management device, displaying a user interface on a display of the management device, the user interface including at least a portion of the data displayed within a graph, the user interface allowing a user to modify a parameter of the titration, receiving a selection of the parameter, based on the selection, determining a titration schedule for the patient, and transmitting the titration schedule to the neurostimulator.